Biological Fluid Transfer Device and Biological Fluid Sampling System

ABSTRACT

A biological fluid sampling transfer device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid sampling transfer device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid sampling transfer device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid sampling transfer device also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid sampling transfer device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid sampling transfer device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.16/425,015, filed May 29, 2019, entitled “Biological Fluid TransferDevice and Biological Fluid Sampling System”, which is a continuation ofU.S. application Ser. No. 14/251,681, filed Apr. 14, 2014, entitled“Biological Fluid Transfer Device and Biological Fluid Sampling System”(now U.S. Pat. No. 10,342,471), which claims priority to U.S.Provisional Application No. 61/811,918, filed Apr. 15, 2013, entitled“Medical Device for Collection of a Biological Sample”, the entiredisclosures of each of which are hereby incorporated by reference intheir entirety.

BACKGROUND OF THE INVENTION 1. Field of the Disclosure

The present disclosure relates generally to devices, assemblies, andsystems adapted for use with vascular access devices. More particularly,the present disclosure relates to devices, assemblies, and systemsadapted for collecting biological samples for use in point-of-caretesting.

2. Description of the Related Art

Blood sampling is a common health care procedure involving thewithdrawal of at least a drop of blood from a patient. Blood samples arecommonly taken from hospitalized, homecare, and emergency room patientseither by finger stick, heel stick, or venipuncture. Blood samples mayalso be taken from patients by venous or arterial lines. Once collected,blood samples may be analyzed to obtain medically useful informationincluding chemical composition, hematology, or coagulation, for example.

Blood tests determine the physiological and biochemical states of thepatient, such as disease, mineral content, drug effectiveness, and organfunction. Blood tests may be performed in a clinical laboratory or atthe point-of-care near the patient. One example of point-of-care bloodtesting is the routine testing of a patient's blood glucose levels whichinvolves the extraction of blood via a finger stick and the mechanicalcollection of blood into a diagnostic cartridge. Thereafter, thediagnostic cartridge analyzes the blood sample and provides theclinician a reading of the patient's blood glucose level. Other devicesare available which analyze blood gas electrolyte levels, lithiumlevels, and ionized calcium levels. Some other point-of-care devicesidentify markers for acute coronary syndrome (ACS) and deep veinthrombosis/pulmonary embolism (DVT/PE).

Despite the rapid advancement in point-of-care testing and diagnostics,blood sampling techniques have remained relatively unchanged. Bloodsamples are frequently drawn using hypodermic needles or vacuum tubesattached to a proximal end of a needle or a catheter assembly. In someinstances, clinicians collect blood from a catheter assembly using aneedle and syringe that is inserted into the catheter to withdraw bloodfrom a patient through the inserted catheter. These procedures utilizeneedles and vacuum tubes as intermediate devices from which thecollected blood sample is typically withdrawn prior to testing. Theseprocesses are thus device intensive, utilizing multiple devices in theprocess of obtaining, preparing, and testing blood samples. Eachadditional device increases the time and cost of the testing process.

Point-of-care testing devices allow for a blood sample to be testedwithout needing to send the blood sample to a lab for analysis. Thus, itis desirable to create a device that provides an easy, safe,reproducible, and accurate process with a point-of-care testing system.

SUMMARY OF THE INVENTION

The present disclosure provides a biological fluid sampling transferdevice, such as a blood sampling transfer device that is adapted toreceive a blood sample having a cellular portion and a plasma portion.After collecting the blood sample, the blood sampling transfer device isable to separate the plasma portion from the cellular portion. Afterseparation, the blood sampling transfer device is able to transfer theplasma portion of the blood sample to a point-of-care testing device.The blood sampling transfer device of the present disclosure alsoprovides a closed sampling and transfer system that reduces the exposureof a blood sample and provides fast mixing of a blood sample with asample stabilizer. The sample stabilizer can be an anticoagulant, or asubstance designed to preserve a specific element within the blood suchas, for example, RNA, protein analyte, or other element. The bloodsampling transfer device is engageable with a blood testing device forclosed transfer of a portion of the plasma portion from the bloodsampling transfer device to the blood testing device. The blood testingdevice is adapted to receive the plasma portion to analyze the bloodsample and obtain test results.

Some of the advantages of the blood sampling transfer device and thebiological fluid separation and testing system of the present disclosureover prior systems are that it is a closed system which reduces bloodsample exposure, it provides passive and fast mixing of the blood samplewith a sample stabilizer, it facilitates separation of the blood samplewithout transferring the blood sample to a separate device, and it iscapable of transferring pure plasma to a point-of-care testing device.The blood sampling transfer device of the present disclosure enablesintegrated blood collection and plasma creation in a closed systemwithout centrifugation. The clinician may collect and separate the bloodsample and then immediately transfer the plasma portion to thepoint-of-care testing device without further manipulation. This enablescollection and transfer of plasma to the point-of-care testing devicewithout exposure to blood. In addition, the blood sampling transferdevice of the present disclosure minimizes process time by processingthe blood within the blood sampling transfer device and without externalmachinery. Further, for tests which only require small amounts of blood,it eliminates the waste associated with blood collection and plasmaseparation with an evacuated tube.

In accordance with an embodiment of the present invention, a biologicalfluid transfer device adapted to receive a multi-component blood sampleincludes a housing having an inlet port and a transfer port, with theinlet port and the transfer port in fluid communication. The device alsoincludes a mixing channel in fluid communication with the inlet port andthe transfer port and shaped to promote mixing of the multi-componentblood sample, and a blood separation element disposed between the inletport and the transfer port. The blood separation element is adapted torestrain a first component of the multi-component blood sample and allowa second component of the multi-component blood sample to passtherethrough.

In one configuration, the first component is a cellular portion of themulti-component blood sample and the second component is a plasmaportion of the multi-component blood sample. The mixing channel mayinclude a sample stabilizer. In certain configurations, the inlet portis adapted to receive the multi-component blood sample via connection toa blood collection set. In other configurations, the inlet port isadapted to receive the multi-component blood sample via connection to acapillary device. In still other configurations, the inlet port isadapted to receive the multi-component blood sample via connection to aneedle device. In still another configuration, the inlet port is adaptedto receive the multi-component blood sample via connection to anintravenous line.

Optionally, the device may also include a wicking membrane adapted tocause the multi-component blood sample to flow into the biological fluidtransfer device. The transfer port may include a bellows and a septumtransitionable between a closed position and an open position, whereincompression of the bellows actuates the septum from the closed positionto the open position. The mixing channel may include a sample stabilizerand the biological fluid transfer device may be a plasma preparationcartridge.

In accordance with another embodiment of the present invention, abiological fluid sampling system, such as a blood sampling system,includes a biological fluid transfer device adapted to receive amulti-component blood sample. The biological fluid transfer deviceincludes a housing having an inlet port and a transfer port, with theinlet port and the transfer port in fluid communication. The device alsoincludes a mixing channel in fluid communication with the inlet port andthe transfer port and shaped to promote mixing of the blood sample, anda separation element disposed between the inlet port and the transferport. The separation element is adapted to restrain a first component ofthe multi-component blood sample and allow a second component of themulti-component blood sample to pass therethrough. The system alsoincludes a first interface removably connectable to the biological fluidtransfer device, the first interface being adapted for connection to afirst blood collection device. The system further includes a secondinterface removably connectable to the biological fluid transfer device,with the second interface being adapted for connection to a second bloodcollection device. The system also includes a packaging member having acompartment sized and adapted to receive the biological fluid transferdevice, the first interface, and the second interface therein.

In certain configurations, the first component is a cellular portion ofthe multi-component blood sample and the second component is a plasmaportion of the multi-component blood sample. The mixing channel mayinclude a sample stabilizer. The inlet port may be adapted to receivethe multi-component blood sample via a blood collection set. In otherconfigurations, the inlet port may be adapted to receive themulti-component blood sample via an intravenous line. In otherconfigurations, the inlet port may be adapted to receive themulti-component blood sample via a capillary device. In still otherconfigurations, the inlet port may be adapted to receive themulti-component blood sample via connection to a needle device.

The device may also include a wicking membrane adapted to cause themulti-component blood sample to flow into the biological fluid samplingtransfer device. The transfer port may include a bellows and a septumtransitionable between a closed position and an open position, whereincompression of the bellows actuates the septum from the closed positionto the open position. In certain configurations, the mixing channelincludes a sample stabilizer and the biological fluid transfer device isa plasma preparation cartridge. Optionally, the first interface includesa spinlock interface. In another configuration, the second interfaceincludes a capillary interface. In yet another configuration, thepackaging member includes a blister package.

In accordance with yet another embodiment of the present invention, abiological fluid separation and testing system for a multi-componentblood sample includes a blood sampling transfer device adapted toreceive the multi-component blood sample. The blood sampling transferdevice includes a housing having an inlet port and a transfer port, withthe inlet port and the transfer port in fluid communication. The devicealso includes a mixing channel in fluid communication with the inletport and the transfer port and shaped to promote mixing of the bloodsample, and a separation element disposed between the inlet port and thetransfer port, the separation element adapted to restrain a firstcomponent of the multi-component blood sample and allow a secondcomponent of the multi-component blood sample to pass therethrough. Thesystem also includes a blood testing device having a receiving portadapted to receive the transfer port of the blood sampling transferdevice for closed transfer of at least a portion of the second componentfrom the blood sampling transfer device to the blood testing device.

In certain configurations, the first component is a cellular portion ofthe multi-component blood sample and the second component is a plasmaportion of the multi-component blood sample. The mixing channel mayinclude a sample stabilizer.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a biological fluid sampling transferdevice in accordance with an embodiment of the present invention.

FIG. 2 is an elevation view of a biological fluid sampling system inaccordance with an embodiment of the present invention.

FIG. 3 is a perspective view of a biological fluid sampling transferdevice in accordance with an embodiment of the present invention, with afirst biological fluid collection device.

FIG. 4 is a perspective view of a biological fluid sampling transferdevice in accordance with an embodiment of the present invention, with asecond biological fluid collection device.

FIG. 5 is a perspective view of a biological fluid sampling transferdevice in accordance with an embodiment of the present invention, with athird biological fluid collection device.

FIG. 6 is a cross-sectional view of the biological fluid samplingtransfer device of FIG. 1 in accordance with an embodiment of thepresent invention.

FIG. 7 is a cross-sectional, top view of a biological fluid samplingtransfer device in accordance with an embodiment of the presentinvention.

FIG. 8 is a perspective view of a biological fluid sampling transferdevice and a point-of-care testing device in accordance with anembodiment of the present invention.

FIG. 9 is a cross-sectional view of a septum of a biological fluidsampling transfer device in accordance with an embodiment of the presentinvention, with the septum in a closed position.

FIG. 10 is a cross-sectional view of a septum of a biological fluidsampling transfer device in accordance with an embodiment of the presentinvention, with the septum in an open position.

FIG. 11 is a schematic representation of a blood separation element of abiological fluid sampling transfer device in accordance with anembodiment of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume alternative variations and step sequences,except where expressly specified to the contrary. It is also to beunderstood that the specific devices and processes illustrated in theattached drawings, and described in the following specification, aresimply exemplary embodiments of the invention. Hence, specificdimensions and other physical characteristics related to the embodimentsdisclosed herein are not to be considered as limiting.

Various point-of-care testing devices are known in the art. Suchpoint-of-care testing devices include test strips, glass slides,diagnostic cartridges, or other testing devices for testing andanalysis. Test strips, glass slides, and diagnostic cartridges arepoint-of-care testing devices that receive a blood sample and test thatblood for one or more physiological and biochemical states. There aremany point-of-care devices that use cartridge based architecture toanalyze very small amounts of blood bedside without the need to send thesample to a lab for analysis. This saves time in getting results overthe long run but creates a different set of challenges versus the highlyroutine lab environment. Examples of such testing cartridges include thei-STAT® testing cartridge from the Abbot group of companies. Testingcartridges such as the i-STAT® cartridges may be used to test for avariety of conditions including the presence of chemicals andelectrolytes, hematology, blood gas concentrations, coagulation, orcardiac markers. The results of tests using such cartridges are quicklyprovided to the clinician.

However, the samples provided to such point-of-care testing cartridgesare currently manually collected with an open system and transferred tothe point-of-care testing cartridge in a manual manner that often leadsto inconsistent results, or failure of the cartridge leading to a repeatof the sample collection and testing process, thereby negating theadvantage of the point-of-care testing device. Accordingly, a needexists for a system for collecting and transferring a sample to apoint-of-care testing device that provides safer, reproducible, and moreaccurate results. Accordingly, a point-of-care collecting andtransferring system of the present disclosure will be describedhereinafter. A system of the present disclosure enhances the reliabilityof the point-of-care testing device by: 1) incorporating a more closedtype of sampling and transfer system; 2) minimizing open exposure of thesample; 3) improving sample quality; 4) improving the overall ease ofuse; and 5) separating the sample at the point of collection.

FIGS. 1-11 illustrate an exemplary embodiment of the present disclosure.Referring to FIGS. 1-11, a biological fluid sampling transfer device orbiological fluid transfer device, such as a blood sampling transferdevice or blood transfer device 10 of the present disclosure is adaptedto receive a blood sample 12 having a cellular portion 14 and a plasmaportion 16. After collecting the blood sample 12, the blood transferdevice 10 is able to separate the plasma portion 16 from the cellularportion 14. After separation, the blood transfer device 10 is able totransfer the plasma portion 16 of the blood sample 12 to a point-of-caretesting device. The blood transfer device 10 of the present disclosurealso provides a closed separation system that reduces the exposure of ablood sample and provides fast mixing of a blood sample with a samplestabilizer.

FIG. 2 illustrates an exemplary embodiment of the present disclosure.Referring to FIG. 2, a biological fluid sampling system, such as a bloodsampling system 30 of the present disclosure includes a kit 31 having ablood sampling transfer device 10, a first interface 32 removablyconnectable to the blood sampling transfer device 10, the firstinterface 32 adapted for connection to a first blood collection device,a second interface 34 removably connectable to the blood samplingtransfer device 10, the second interface 34 adapted for connection to asecond blood collection device, and a packaging member 36 having acompartment 38 sized and adapted to receive the blood sampling transferdevice 10, the first interface 32, and the second interface 34 therein.

FIG. 8 illustrates an exemplary embodiment of the present disclosure.Referring to FIG. 8, a blood separation and testing system 20 of thepresent disclosure includes a blood sampling transfer device 10 and ablood testing device or point-of-care testing device 22 engageable withthe blood sampling transfer device 10 for closed transfer of a portionof the plasma portion 16 (FIG. 11) from the blood sampling transferdevice 10 to the blood testing device 22. The blood testing device 22 isadapted to receive the plasma portion 16 to analyze the blood sample andobtain test results.

Some of the advantages of the blood sampling transfer device and theblood separation and testing system of the present disclosure over priorsystems are that it is a closed system which reduces blood sampleexposure, it provides passive and fast mixing of the blood sample with asample stabilizer, it facilitates separation of the blood sample withouttransferring the blood sample to a separate device, and it is capable oftransferring pure plasma to a point-of-care testing device. The bloodsampling transfer device of the present disclosure enables integratedblood collection and plasma creation in a closed system withoutcentrifugation. The clinician may collect and separate the blood sampleand then immediately transfer the plasma portion to the point-of-caretesting device without further manipulation. This enables collection andtransfer of plasma to the point-of-care testing device without exposureto blood. In addition, the blood sampling transfer device of the presentdisclosure minimizes process time by processing the blood within theblood sampling transfer device and without external machinery. Further,for tests which only require small amounts of blood, it eliminates thewaste associated with blood collection and plasma separation with anevacuated tube.

Referring to FIGS. 1-11, a blood sampling transfer device 10 generallyincludes a housing 50 having an inlet port 52, an outlet port ortransfer port 54 in fluid communication with the inlet port 52, a flowchannel or a mixing channel 56 in fluid communication with the inletport 52 and the transfer port 54, a blood separation element 58 disposedbetween the inlet port 52 and the transfer port 54, a valve or septum 86disposed at the transfer port 54, an interface connection portion 60,and an exit channel 68. The interface connection portion 60 allows thefirst interface 32 or the second interface 34 to be removably connectedto the blood sampling transfer device 10 to allow for the collection ofa blood sample 12 into the blood sampling transfer device 10.

Referring to FIG. 2, a blood sampling system 30 of the presentdisclosure includes a kit 31 having a blood sampling transfer device 10,a first interface 32 removably connectable to the blood samplingtransfer device 10, the first interface 32 adapted for connection to afirst blood collection device, a second interface 34 removablyconnectable to the blood sampling transfer device 10, the secondinterface 34 adapted for connection to a second blood collection device,and a packaging member 36 having a compartment 38 sized and adapted toreceive the blood sampling transfer device 10, the first interface 32,and the second interface 34 therein.

The packaging member 36 includes a body or wall 46 defining acompartment 38. In one embodiment, the body 46 of the packaging member36 defines a first compartment 40 sized and adapted to receive the bloodsampling transfer device 10 therein, a second compartment 42 sized andadapted to receive the first interface 32 therein, and a thirdcompartment 44 sized and adapted to receive the second interface 34therein. In one embodiment, the packaging member 36 comprises a blisterpackage. In one embodiment, a sealing cover is secured over thepackaging member 36 to seal the blood sampling transfer device 10, thefirst interface 32, and the second interface 34 therein, i.e., thesealing cover provides a substantially impermeable enclosure withrespect to packaging member 36, provides a leak prevention andprotection enclosure, protects the contents of the blood samplingtransfer device 10 and the interfaces 32, 34 contained within packagingmember 36, and/or maintains a sealed, sterilized environment withinpackaging member 36. The sealing cover of the packaging member 36provides a sufficient seal at a range of temperatures, pressures, andhumidity levels. In one embodiment, tamper evidence is also provided byuse of a tear strip or other indicating means secured to a portion ofthe sealing cover and/or packaging member 36 to indicate tampering withthe contents of packaging member 36.

In one embodiment, the blood sampling transfer device 10 is a plasmapreparation cartridge. In one embodiment, the first interface 32 is aspinlock interface. In one embodiment, the second interface 34 is acapillary collection interface. In one embodiment, the packaging member36 is a blister package. The system of the present disclosure allows theblood sampling transfer device 10 to receive a blood sample from avariety of sources including, but not limited to, an integralmicro-needle device or lancet device 62 (FIG. 6), a blood collection set100 (FIG. 3), an intravenous line or PICC line 104 (FIG. 4), a capillarydevice or needle device 106 (FIG. 5), or a finger-stick capillary bed(not shown).

In one embodiment, there are three primary ways a user can collect bloodinto the blood sampling transfer device 10. For example, these ways maybe as follows: 1) venous blood via venipuncture and connecting to ablood collection set 100 or IV with the first interface 32 and aresealable valve or septum (arterial draws may be accomplished byconnecting this interface system to an indwelling line); 2) capillaryblood via a capillary stick with a lancet on a finger of the patientwith the second interface 34; and 3) venous-like blood by using themicro-needle device 62 to puncture the arm of a patient. This universalapproach offers the greatest flexibility in allowing the clinician todetermine what is best for the patient under his or her care. In otherembodiments, there are additional ways a user can collect blood into theblood sampling transfer device 10.

Referring to FIG. 3, in one embodiment, the inlet port 52 is adapted tobe connected to a blood collection set 100 via the first interface 32 toallow for the collection of a blood sample 12 into the blood samplingtransfer device 10. The inlet port 52 may be sized and adapted forengagement with a separate device, such as a needle assembly or IVconnection assembly and, therefore, may include a mechanism for suchengagement as is conventionally known. For example, in one embodiment,the inlet port 52 may include a luer lock or luer tip for engagementwith an optional separate luer mating component of such a separatedevice for attachment therewith. For example, referring to FIG. 3, theblood collection set 100 may include a luer component 102 for engagementwith inlet port 52 of blood sampling transfer device 10. In this manner,the inlet port 52 is connectable to the blood collection set 100 for thecollection of a blood sample into the blood sampling transfer device 10.In addition, a mechanism for locking engagement between the inlet port52 and the blood collection set 100 may also be provided. Such luerconnections and luer locking mechanisms are well known in the art. Theblood collection set 100 may include a needle assembly, an IV connectionassembly, a PICC line, an arterial indwelling line, or similar bloodcollection means.

Referring to FIG. 7, the inlet port 52 is in fluid communication withthe transfer port 54 via the mixing channel 56. The inlet port 52 mayalso include a resealable septum that is transitionable between a closedposition and an open position. With the septum in an open position, ablood sample 12 may flow through the inlet port 52 to the mixing channel56.

The blood sampling transfer device 10 also includes a layer of samplestabilizer 64. The sample stabilizer can be an anticoagulant, or asubstance designed to preserve a specific element within the blood suchas, for example, RNA, protein analyte, or other element. In oneembodiment, the layer of sample stabilizer 64 may be disposed over theblood separation element 58. In one embodiment, a portion of the mixingchannel 56 includes the sample stabilizer 64. In other embodiments, thelayer of sample stabilizer 64 may be located anywhere between the inletport 52 and the blood separation element 58. In this manner, as a bloodsample 12 flows through the inlet port 52 and into the mixing channel56, the blood sampling transfer device 10 provides passive and fastmixing of the blood sample 12 with the sample stabilizer 64.

The blood sampling transfer device 10 includes a blood separationelement 58 disposed between the inlet port 52 and the transfer port 54.The blood separation element 58 is adapted to trap the cellular portion14 of the blood sample 12 within the mixing channel 56 and allow theplasma portion 16 of the blood sample 12 to pass through the bloodseparation element 58 to the exit channel 68 as shown in FIG. 11.

In one embodiment, the blood separation element 58 may be either hollowfiber membrane filters commercially available, or flat membrane filters,such as track-etch filters commercially available. Membrane filter poresize and porosity can be chosen to optimize separation of clean (i.e.,red blood cell free, white blood cell free, and platelet free) plasma inan efficient manner. In another embodiment, the blood separation element58 includes a lateral flow membrane. In other embodiments, the bloodseparation element 58 may comprise any filter that is able to trap thecellular portion 14 of the blood sample 12 within the mixing channel 56and allow the plasma portion 16 of the blood sample 12 to pass throughthe blood separation element 58 to the exit channel 68.

Referring to FIG. 6, in one embodiment, the blood sampling transferdevice 10 includes an integral micro-needle device or lancet device 62.The blood sampling transfer device 10 includes a bottom surface 72defining an opening 70 and a top surface 74. The integral micro-needledevice 62 may be positioned adjacent the top surface 74. The lancet ormicro-needle device 62 includes a puncturing element 63 and is adaptedfor movement between a pre-actuated position wherein the puncturingelement 63 is retained within the housing 50 and a puncturing positionwherein at least a portion of the puncturing element 63 extends throughthe opening 70 of the housing 50. In such an embodiment, the bloodsampling transfer device 10 includes a wicking membrane 66 adapted topull the blood sample through the opening 70 into the blood samplingtransfer device 10 after the skin of a patient is punctured by thelancet or micro-needle device 62.

In one embodiment, the bottom surface 72 of the housing 50 includes anadhesive. In such an embodiment, the bottom surface 72 includes anadhesive so that the blood sampling transfer device 10 can be securedonto a skin surface of a patient where a blood sample will be accessedusing the lancet or micro-needle device 62. In one embodiment, theadhesive of the bottom surface 72 is protected by a peel-off layer,similar to an adhesive bandage, which would be removed before placingthe blood sampling transfer device 10 on the skin surface of thepatient's body. A hydrogel or other layer (not shown) could be includedto provide some thickness to the bottom surface 72 and help improve thestability of the adhesive seal. Additionally, in one embodiment, theadhesive could include a chemistry to create a more liquid-tight seal,similar to painter's tape technology, where wetting from the paintitself causes a chemical reaction with the adhesive to create a morewater-tight barrier to prevent the paint from seeping under the tape. Incertain cases, the blood sample collected on a top surface of theadhesive tape may be of better quality than blood samples collected byuse of a typical lancet by minimizing contact with the skin surface.

Referring to FIG. 7, in one embodiment, the mixing channel 56 comprisesa serpentine or spiral shape to promote efficient mixing of a bloodsample having a cellular portion and a plasma portion. In otherembodiments, the mixing channel 56 comprises other shapes to promoteefficient mixing of a blood sample.

Referring to FIG. 8, a blood testing device or point-of-care testingdevice 22 includes a receiving port 24 adapted to receive the transferport 54 of the blood sampling transfer device 10. The blood testingdevice 22 is adapted to receive the transfer port 54 of the bloodsampling transfer device 10 for closed transfer of a portion of theplasma portion 16 (FIG. 11) from the exit channel 68 of the bloodsampling transfer device 10 to the blood testing device 22. The bloodtesting device 22 is adapted to receive the plasma portion 16 to analyzethe blood sample and obtain test results.

As discussed above, the transfer port 54 of the blood sampling transferdevice 10 may include a valve or septum 86 that is transitionablebetween a closed position and an open position. With the valve or septum86 in an open position (FIG. 10), the plasma portion 16 of the bloodsample 12 may flow through the transfer port 54 to a blood testingdevice or a point-of-care testing device 22.

In one embodiment, referring to FIGS. 9 and 10, the valve 86 maygenerally include a transfer channel 90, a bellows or deformable wallmember 92, and a septum or barrier 94 having a first barrier wall 96 anda second barrier wall 98. Referring to FIG. 9, the valve 86 is in aclosed position to prevent the plasma portion 16 of the blood sample 12from flowing through the transfer port 54. In this manner, the plasmaportion 16 is sealed within the blood sampling transfer device 10.Referring to FIG. 10, the valve 86 is in an open position so that theplasma portion 16 of the blood sample 12 may flow through the transferport 54 to a blood testing device or a point-of-care testing device 22.

Referring to FIG. 10, with the plasma portion 16 received within thetransfer port 54 of the blood sampling transfer device 10, the transferport 54 of the blood sampling transfer device 10 is then positioned overthe receiving port 24 of the point-of-care testing device 22. Pushingdown in the direction of arrow B compresses the deformable wall member92 and opens up the first barrier wall 96 and the second barrier wall 98of the septum 94 as shown in FIG. 10. With the valve 86 in the openposition, the plasma portion 16 of the blood sample 12 is allowed toflow through the transfer port 54 and the receiving port 24 to thepoint-of-care testing device 22 in a closed manner, reducing exposure tothe clinician and the patient.

The valve 86 of the blood sampling transfer device 10 only opens whenthe transfer port 54 is pressed upon the receiving port 24 of thepoint-of-care testing device 22. This releases the isolated plasmaportion 16 directly into the receiving port 24 of the point-of-caretesting device 22, thus mitigating unnecessary exposure to the patient'sblood.

Referring to FIGS. 1-11, use of a blood sampling transfer device of thepresent disclosure will now be described. Referring to FIGS. 1-6, a usercan select one of the ways, sources, or methods that the blood samplingtransfer device 10 is able to receive a blood sample. For example, thesystem of the present disclosure allows the blood sampling transferdevice 10 to receive a blood sample from a variety of sources including,but not limited to, an integral micro-needle device or lancet device 62(FIG. 6), a blood collection set 100 (FIG. 3), an intravenous line orPICC line 104 (FIG. 4), a capillary device or needle device 106 (FIG.5), or a finger-stick capillary bed (not shown).

Once a desired method or source is selected, the interface connectionportion 60 of the blood sampling transfer device 10 allows the firstinterface 32 or the second interface 34 to be removably connected to theblood sampling transfer device 10 to allow for the collection of a bloodsample 12 into the blood sampling transfer device 10. The blood samplingtransfer device 10 is designed to be a closed system for bloodcollection from various collection sites as described above. Once bloodenters the blood sampling transfer device 10 from one of the aboveselected sources, it is mixed with a sample stabilizer as it travelsthrough the microfluidic mixing channel 56 via capillary action. Next,the blood sample 12 travels through the mixing channel 56 and the bloodseparation element 58 is adapted to trap the cellular portion 14 of theblood sample 12 within the mixing channel 56 and allow the plasmaportion 16 of the blood sample 12 to pass through the blood separationelement 58 to the exit channel 68 as shown in FIG. 11.

After disconnecting or removing the blood sampling transfer device 10from the selected source, the blood sampling transfer device 10 may beengaged with a blood testing device 22. The transfer port 54 may beplaced over the receiving port 24 of the point-of-care testing device 22as shown in FIG. 8. The clinician then presses the transfer port 54against the receiving port 24 of the point-of-care testing device 22 inthe direction of arrow B to open the valve 86 (FIG. 10) and to transferthe collected plasma portion 16 to the point-of-care testing device 22in a closed manner, reducing exposure to the clinician and the patient.The blood testing device 22 is adapted to receive the transfer port 54of the blood sampling transfer device 10 for closed transfer of aportion of the plasma portion 16 from the blood sampling transfer device10 to the blood testing device 22. The blood testing device 22 isadapted to receive the plasma portion 16 to analyze the blood sample andobtain test results.

Some of the advantages of the blood sampling transfer device and theblood separation and testing system of the present disclosure over priorsystems are that it is a closed system which reduces blood sampleexposure, it provides passive and fast mixing of the blood sample with asample stabilizer, it facilitates separation of the blood sample withouttransferring the blood sample to a separate device, and it is capable oftransferring pure plasma to the point-of-care testing device 22. Theblood sampling transfer device of the present disclosure enablesintegrated blood collection and plasma creation in a closed systemwithout centrifugation. The clinician may collect and separate the bloodsample and then immediately transfer the plasma portion to thepoint-of-care testing device 22 without further manipulation. Thisenables collection and transfer of plasma to the point-of-care testingdevice 22 without exposure to blood. In addition, the blood samplingtransfer device of the present disclosure minimizes process time byprocessing the blood within the blood sampling transfer device andwithout external machinery. Further, for tests which only require smallamounts of blood, it eliminates the waste associated with bloodcollection and plasma separation with an evacuated tube.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A biological fluid transfer device adapted toreceive a multi-component blood sample, the biological fluid transferdevice comprising: a housing comprising a transfer port, a top surface,and a bottom surface, wherein the bottom surface defines an openingtherethrough, the opening of the housing being in fluid communicationwith the transfer port; a micro-needle device positioned adjacent thetop surface of the housing, wherein the micro-needle device comprises apuncturing element configured for movement between a pre-actuatedposition and a puncturing position; and a blood separation elementdisposed in the housing between the opening and the transfer port,wherein the porous blood separation element comprises a filterconfigured to restrain a first component of the multi-component bloodsample and allow a second component of the multi-component blood sampleto pass therethrough.
 2. The biological fluid transfer device of claim1, further comprising a blood sample stabilizer layer disposed betweenthe opening of the housing and the blood separation element.
 3. Thebiological fluid transfer device of claim 2, wherein the blood samplestabilizer layer comprises an anticoagulant.
 4. The biological fluidtransfer device of claim 2, further comprising a wicking membranedisposed between the opening and the blood separation element, whereinthe wicking membrane is configured to pull the multi-component bloodsample through the opening of the housing.
 5. The biological fluidtransfer device of claim 4, wherein the blood sample stabilizer layer ispositioned between the wicking membrane and the blood separationelement.
 6. The biological fluid transfer device of claim 1, wherein, inthe pre-actuated position, the puncturing element of the micro-needledevice is retained within the housing.
 7. The biological fluid transferdevice of claim 1, wherein, in the puncturing position, at least aportion of the puncturing element of the micro-needle device extendsthrough the opening of the housing.
 8. The biological fluid transferdevice of claim 1, wherein the transfer port comprises one of a valve orseptum.
 9. The biological fluid transfer device of claim 8, wherein oneof the valve or septum is transitionable between a closed position andan open position.
 10. The biological fluid transfer device of claim 1,further comprising a mixing channel within the housing.
 11. Thebiological fluid transfer device of claim 10, wherein the mixing channelcomprises a structural shape configured to promote mixing of themulti-component blood sample.
 12. The biological fluid transfer deviceof claim 11, wherein the structural shape is one of a serpentine orspiral shape.
 13. The biological fluid transfer device of claim 1,further comprising an adhesive layer formed on the bottom surface of thehousing.
 14. The biological fluid transfer device of claim 13, furthercomprising a peel-off layer provided over, and removable from, theadhesive layer.
 15. A biological fluid transfer device adapted toreceive a multi-component blood sample, the biological fluid transferdevice comprising: a housing comprising a transfer port, a top surface,and a bottom surface, wherein the bottom surface defines an openingtherethrough, the opening of the housing being in fluid communicationwith the transfer port; an integrated lancet device positioned adjacentthe top surface of the housing, wherein the integrated lancet devicecomprises a puncturing element configured for movement between apre-actuated position and a puncturing position; a blood separationelement disposed in the housing between the opening and the transferport; and a wicking membrane disposed between the opening of the housingand the blood separation element, wherein the wicking membrane isconfigured to pull the multi-component blood sample through the openingof the housing.
 16. The biological fluid transfer device of claim 15,further comprising a blood sample stabilizer layer disposed between theopening of the housing and the blood separation element.
 17. Thebiological fluid transfer device of claim 16, wherein the blood samplestabilizer layer is positioned between the wicking membrane and theblood separation element.
 18. The biological fluid transfer device ofclaim 15, wherein, in the pre-actuated position, the puncturing elementof the integrated lancet device is retained within the housing and, inthe puncturing position, at least a portion of the puncturing element ofthe integrated lancet device extends through the opening of the housing.19. The biological fluid transfer device of claim 15, further comprisingan adhesive layer formed on the bottom surface of the housing.
 20. Thebiological fluid transfer device of claim 19, further comprising apeel-off layer provided over, and removable from, the adhesive layer.